Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091120
Company: HIKMA FARMACEUTICA
Company: HIKMA FARMACEUTICA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TESTOSTERONE ENANTHATE | TESTOSTERONE ENANTHATE | 200MG/ML | INJECTABLE;INJECTION | Prescription | AO | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
09/18/2012 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/29/2020 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
09/08/2015 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
11/21/2014 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
TESTOSTERONE ENANTHATE
INJECTABLE;INJECTION; 200MG/ML
TE Code = AO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TESTOSTERONE ENANTHATE | TESTOSTERONE ENANTHATE | 200MG/ML | INJECTABLE;INJECTION | Prescription | No | AO | 212659 | EUGIA PHARMA |
TESTOSTERONE ENANTHATE | TESTOSTERONE ENANTHATE | 200MG/ML | INJECTABLE;INJECTION | Prescription | No | AO | 091120 | HIKMA FARMACEUTICA |
TESTOSTERONE ENANTHATE | TESTOSTERONE ENANTHATE | 200MG/ML | INJECTABLE;INJECTION | Prescription | No | AO | 040575 | NEXUS |